Wednesday, February 8, 2012

It's true, fake drugs flooding markets

Sangita Jha/New Delhi

You can contest the figures rolled out by pharma lobby, but that doesn't mean the scare is baseless. Spurt in crackdown shows spurious drug industry is growing.

While the government is of the view that the spurious drug size is as low as 0.04 per cent, spate of arrests made by police in various parts of the country tell a different story. Also, there is a section which is of the view that spurious drug scare is being exaggerated by the lobby of the multi-national companies.
Notwithstanding difference of opinion in the government and the pharma community, there appears a clear case that a large number of patients across the country are being taken for a ride. What is worse is that someone having bought a counterfeit electronic product may just rue the fact that he has been fleeced of his hard earned money, the victims of spurious drugs in some instances may pay with his life as well. So, there is no difference of opinion that spurious drugs can kill.
The Central government on the basis of a study conducted by the Ministry of health which had a sample size of 6000 chemists across the country maintains that the spurious drug size in the country is as low as 0.04 per cent. However, the industry experts peg it to be anywhere between 10 per cent to 30 per cent. Clearly, the range is quite wide and one can take liberty to come to his conclusion, that the actual spurious drug size could be anywhere between the government and industry's estimates.
Critics of the health ministry's findings question if the chemists would keep the spurious drugs on the shelf at their shops to invite the censure. The sample of the study conducted by the ministry of health was on the basis of random shopping of medicines done at 6,000 chemists. The critics do have a point that an organised racket of spurious drugs could have a modus operandi to escape the ambit of the study of the health ministry.
Delhi and the National Capital Territory Region (NCR) are considered the conduit for the distribution of the spurious drugs across the country. A number of arrests by the police in the national capital have revealed that the manufacturing base of spurious drugs is spread from the western Uttar Pradesh to the neighbouring areas of Haryana, Punjab and Himachal Pradesh. In fact, the Minister of state for home affairs Mullappally Ramachandran had informed the Parliament in a written answer that 10 people were arrested in 2011 for involvement in the production and distribution of spurious drugs in Delhi, while two cases of spurious drugs production and distribution racket were registered in the national capital last year. He had stated that there were five such cases in 2010 and six cases in 2009, while in 2008 there was just one case.
Mr Ramachandran's statement in the Lok Sabha does point to one clear indicator, that cases of spurious drugs being registered by the police are on the rise. And also that there could be a bigger network of those involved in the manufacture and distribution of spurious drugs evading the eyes of the police.
The industry on the other hand is of the view that the low estimate of the government of spurious drugs could also be due to the definition of counterfeit. In fact, Tapan Ray, director general, Organization of Pharmaceutical Producers of India (OPPI), had earlier stated "anything that is not genuine is counterfeit". Section 17 of Drugs and Cosmetics act 1940 specifies that spurious, adulterated and misbranded are counterfeits. Regulators do not agree on definition of counterfeits.
Many pharmaceutical companies manufacture drugs at third party facilities. When the pharma companies squeeze margins, third party manufacturers resorts to diverting additional production to market without original manufacturer name and selling at lower price because of lack of marketing costs. These are called legal counterfeits by the pharma experts.
However, Mr Ray had suggested three-pronged approach to fight against spurious drugs by way of legal enforcement, consumer awareness and deterrent to seller, and technology to differentiate between genuine and fake.
India has put in place a strong legal safeguard against menace of spurious drugs. The ministry of health and family welfare has notified and implemented the "Drugs and Cosmetics (Amendment) Act, 2008", significantly increasing the penalty for manufacture of spurious or adulterated drugs. The amended Act enhances the penalty for manufacture of spurious drugs to a minimum imprisonment of 10 years, which may extend to a life term, and a minimum fine of Rs 10 lakh or three times the value of the drugs confiscated, whichever is higher. And it makes the offence non-bailable in some cases.
While the legal mechanism has been put in place, the industry is of the view that the government should encourage whistleblowers along with enough safeguards to ensure that those indulging the trade of manufacture of spurious drugs are apprehended with no loss of time.
A glance at the number of arrests made by Delhi police in the last year may alarm of the people at large of the extent of the spurious drugs' reach. For example, police raids carried out at central Delhi's medical wholesale market, Bhagirath Place, and subsequently also in Agra on June 3 and June 6 respectively yielded spurious drugs worth Rs 8 lakh drugs worth Rs 34 lakh. The police later said that a total of 115 different kinds of drugs were being sold without any licence by this gang. Racketeers may have stamped the spurious medicines with the names of different government agencies to authenticate them so that people will assume that these medicines are genuine and purchase them, DCP (crime) Ashok Chand, who had led the raiding team, had said.
Worst part was that almost the entire lot recovered from Agra turned out to be expired drugs. They were pushed into north Indian markets after recycling. Worse, a senior official of a pharmaceutical company, who accompanied the raiding party, told the police that 45 ampoules of seized 'Susten 100' injections, used by pregnant women, were also spurious. Other medicines included those meant to cure heart ailment and diabetes.
In another catch, the police busted a spurious drugs manufacturing unit in Uttar Pradesh and stumbled upon fake drugs worth more than Rs 1 crore. Following interrogation of those arrested, the police seized huge quantity of reputed antibiotics and pain-killers worth more than Rs 1.37 crores. The police later said that following tip-off they nabbed 92 boxes of Voveran. Among the seized items were 26 lakh spurious tablets of diclofenac sodium, 14,000 spurious Voveran tablets, 600 empty boxes of Voveran, 25 empty boxes of Nor TZ, one strip packing machine, a tablet printing machine, two dye rollers, 11 rubber stamps and 4,500 Novartis stickers among other things. Delhi police officials maintain that there exists network of racketeers which ship the spurious drugs from the northern parts to as far as West Bengal, Orissa and Bihar.
The spurious drugs not only threaten the prospects of an industry worth Rs 75,000 crore by revenue but at the same time put the lives of a large number of patients at risk. Therefore, the government and the industry need to join hands in finding a solution to the menace by giving top priority to the safety of the patients.

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